CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12Appendix A-25Enrolled subjects were representative of healthy individuals with no history of eye diseaseand were carefully screened and evaluated for eligibility. After undergoing a generalophthalmic examination, qualifying and consented subjects underwent retinal scanningwith the CIRRUS HD-OCT instrument. Medical and ophthalmic histories were taken prior toenrolling the subjects in the study. Subjects were given a complete ophthalmic examinationthat included the following tests:• Distance visual acuity.• Perimetry using the Humphrey 24–2 SITA Standard threshold test, bilaterally. Anydefects found were verified with a second test.• Goldmann application tonometry.• Keratometry.• Axial length measurement using an IOLMaster.• Slit lamp examination of the anterior segment of both eyes.• Gonioscopy.• Dilated ophthalmoscopic examination, bilaterally.• Fundus and stereodisc photography of the maculas and the optic nerves of both eyes.• Corneal thickness measurement using ultrasound pachymetry.Subjects were grouped into six categories, by subject age: 18–29, 30–39, 40–49, 50–59,60–69, and 70–80. It should be noted that this normative database does not have anysubject younger than 19 years old or older than 79 years old.Inclusion and Exclusion CriteriaInclusion and exclusion criteria for enrollment in the study were as follows:Inclusion Criteria• Males or females 18 years of age or older.• Able and willing to make the required study visits.• Able and willing to give consent and follow study instructions.• Must have a normal and valid Humphrey 24–2 SITA Standard visual field in both eyes.Exclusion CriteriaOphthalmic:• Best corrected visual acuity in either eye worse than 20/40.• Refractive error (spherical equivalent) outside –12.00 D to +8.00 D range.• Glaucoma or glaucoma suspect diagnosis in either eye.• Presence or history of ocular hypertension (IOP ≥22 mm Hg) in either eye.• Occludable angle or history of angle closure in either eye.• Presence or history of disc hemorrhage in either eye.• Presence of RNFL defect in either eye.• Presence of amblyopia in either eye.• Previous laser or incisional surgery.• Any active infection of anterior or posterior segments.
